BioXcel Therapeutics, Inc. is a biopharmaceutical firm that has reached the commercial phase, distinguishing itself by leveraging artificial intelligence to advance the creation of transformative therapies in the fields of neuroscience and immuno-oncology. Their distinctive methodology, termed 'drug re-innovation,' involves harnessing the power of big data and proprietary machine learning algorithms to uncover novel therapeutic applications for existing approved medications or drug candidates with established clinical validation. The company's flagship commercial offering, IGALMI (known during development as BXCL501), is a unique sublingual film delivering dexmedetomidine, designed for the rapid management of agitation experienced by adults with schizophrenia or bipolar I or II disorder. Beyond its current commercial use, BXCL501 is also undergoing further clinical investigation. Studies are underway to assess its efficacy for agitation in individuals with Alzheimer's disease, as an add-on therapy for major depressive disorder, and for use in community settings to address agitation linked to bipolar disorders and schizophrenia. Furthermore, BioXcel is advancing BXCL502, a candidate therapy targeting chronic agitation prevalent in dementia patients. Another key pipeline asset is BXCL701, an orally administered systemic innate immunity activator currently under investigation. This compound shows promise for treating aggressive prostate cancer and advanced solid tumors that have either become resistant to checkpoint inhibitors or have not yet received such treatment. Established in 2017, the company maintains its headquarters in New Haven, Connecticut.
BioXcel Therapeutics Presents New Data from SERENITY At-Home Phase 3 Trial for Agitation Associated with Bipolar Disorders or Schizophrenia at 2026 ASCP Annual Meeting
BioXcel Therapeutics presented new positive exploratory efficacy data from its Phase 3 SERENITY At-Home trial for BXCL501 at the 2026 ASCP Annual Meeting.
The data showed that sublingual dexmedetomidine reduced agitation compared to placebo across all baseline severity levels, with the most pronounced effect in severe cases, and maintained benefit with repeated dosing over 12 weeks.
The FDA has set a PDUFA target action date of November 14, 2026, for the company’s supplemental New Drug Application for IGALMI for at-home use, positioning BXCL501 as a potential first-in-class treatment for acute agitation in this setting.